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Adverse Event Reporting System
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#	Item
431	A. Adverse Event Reports 1. Background Add to Reading List Source URL: www.fda.gov Language: English Health Pharmaceutical sciences Pharmacology Clinical research Pharmaceutical industry Adverse Event Reporting System Adverse event MedWatch Pharmacovigilance Food and Drug Administration Medicine Drug safety
432	OFFICE OF DRUG SAFETY (ODS) • Desired Outcome Reduce preventable deaths and injuries associated with the use of medical products Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Pharmaceutical sciences Pharmacovigilance Adverse effect MedWatch Center for Drug Evaluation and Research Adverse Event Reporting System Criticism of the Food and Drug Administration Medicine Food and Drug Administration Health
433	Form Approved: OMB No[removed]Expiration Date: [removed]See PRA Statement below) DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2013-06-03 10:09:56 Pharmacology Health Pharmaceutical industry MedWatch Adverse Event Reporting System Medical device Infant formula Adverse event Food and Drug Administration Medicine Pharmaceutical sciences
434	Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submissions; Requirements; Final Rule Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Safety United States administrative law United States Public Health Service Pharmacovigilance Regulatory Flexibility Act Vaccine Adverse Event Reporting System Pharmaceutical sciences Drug safety Pharmacology
435	Frequently Asked Questions Add to Reading List Source URL: www2.aap.org Language: English - Date: 2013-06-28 11:07:55 Vaccines Vaccination Drug safety Immunization registry Vaccine Adverse Event Reporting System Vaccine HPV vaccine Anthrax vaccines Medicine Health Prevention
436	Introductory statement preceding the AE portion of AC: Add to Reading List Source URL: www.fda.gov Language: English - Date: 2005-06-28 09:23:41 Food and Drug Administration Clinical research Pharmaceutical industry Drug safety Adverse Event Reporting System Adverse event Pharmacovigilance MedWatch Clinical trial Pharmacology Pharmaceutical sciences Medicine
437	Improving Patient Safety by Reporting Problems with In Vitro Diagnostic Devices Medical Product Safety Network Add to Reading List Source URL: www.fda.gov Language: English Patient safety Pharmaceutical industry Hospice Medical error Adverse event Laboratory information system Food and Drug Administration IVD Calibration Medicine Health Medical technology
438	MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH Add to Reading List Source URL: www.fda.gov Language: English - Date: 2005-06-28 09:23:54 Adverse Event Reporting System Food and Drug Administration Drug safety Paricalcitol Pharmacovigilance Adverse event Pharmaceutical sciences Pharmacology Clinical research
439	Guidance for Industry: MedWatch Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Center for Biologics Evaluation and Research Adverse effect Adverse Event Reporting System MedWatch Allotransplantation Adverse event Medical device Medicine Food and Drug Administration Health
440	Briefing Materials for the March 3, 2014 Meeting of the Pediatric Advisory Committee Add to Reading List Source URL: www.fda.gov Language: English Piperazines Chemistry Food and Drug Administration Pharmaceutical industry Adverse Event Reporting System New Drug Application Norfloxacin Pharmacovigilance Drug development Pharmaceutical sciences Pharmacology Drug safety

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